1. Lecture 4 Hard or Sharp Foreign Objects in Food

2. Student Learning Outcomes
Understand hazards associated with hard or sharp foreign objects in foods and methods to control the hazards
Understand the sizes of hard or sharp objects that cause injury or trauma
Be able to list potential sources of hard or sharp objects in a flour mill, feed mill, or a bakery
Assessment by instructor: Answers to questions in the first lecture exam

3. Foreign Objects as Physical Hazards
Potentially Hazardous: Hard and sharp foreign objects
Glass, metal fragments
Cause traumatic injury (laceration and perforation)
Non-Hazardous:
Tiny metal shavings while opening canned food
Insects, mites, rodent filth

4. Naturally Occurring Hard Objects
Bones in seafood
-Consumer’s awareness eliminates hazard
Exception: when the food label claims that naturally occurring hard objects have been removed
Consumer’s awareness is lacking
Examples: Pit fragments in pitted olives (DALs)
Average of 1.3% or more by count of olives with whole pits and/or pit fragments 2 mm or longer measured in the longest dimension

5. Main Materials of Concern as Physical Hazards and Common Sources (Hyman et al. 1991)
Injury Potential
Sources
Glass
Cuts, bleeding; may require surgery to find or remove
Bottles, jars, light fixtures, utensils, gauge covers
Wood
Cuts, infection, choking; may require surgery to remove
Fields, pallets, boxes, buildings
Stones
Choking, broken teeth
Fields, buildings
Bullet/BB Shot/Needles
Cuts, infection; may require surgery to remove
Animals shot in field, hypodermic needles used for infections.
Jewelry
Pens/pencils, buttons, careless employee practices.
Metal
Machinery, fields, wire, employees
Insects and other filth
Illness, trauma, choking
Fields, plant post-process entry
Insulation
Choking; long-term if asbestos
Building materials
Bone
Choking, trauma
Fields, improper plant processing
Plastic
Choking, cuts, infection; may require surgery to remove
Fields, plant packaging materials, pallets, employees
Personal effects
Choking, cuts, broken teeth; may require surgery to remove
Employees

6. FDA Definition of Foreign Objects that Pose a Physical Hazard
There is clinical evidence of physical trauma or injury from ingestion
Medical authorities recognize the type of object as a potential ingestion hazard
Subsequent processing or intended use of the product does not eliminate or neutralize the hazard

7. Hard or Sharp Foreign Objects
Trauma
FDA: 7 mm or larger; 2 mm could be a risk to elderly or infants
USDA: Over 7 mm is hazardous; 2-7 mm is non-hazardous
Health Canada: 2 mm or greater
Does not apply to naturally occurring hard or sharp objects
Choking hazards
The Consumer Product Safety Commission: 25 mm or larger is NOT a choking hazard
Sources
Raw materials
From machinery/equipment
Glass fixtures

8. FDA Compliance Policy Guide http://www. fda
FDA Compliance Policy Guide (March 23, 1999)
FDA Health Hazard Evaluation Board
Evaluated 190 cases (injury and non-injury cases)
Objects <7 mm rarely cause injury or trauma, except in elderly, infants, and surgery patients
Regulatory action: Seizure (Div. Compliance Mgmt. & Operations)
Product contains object 7-25 mm long
Product is ready-to-eat
Minimal preparation does not neutralize the hazard
Product is considered adulterated, within the meaning of 342 (a) (1)

9. If there is a hazard, product is deemed adulterated (342 (a) (1))
Regulatory action: Legal action pending review (CFSAN Office of Field Programs, Div. Enforcement Programs)
Product contains object 7-25 mm long and will be subjected to further preparation or processing or
Product contains object <7 mm long and is intended for consumption by the sensitive groups
Product contains object over 25 mm long
If there is a hazard, product is deemed adulterated (342 (a) (1))
If there is no hazard for the first two product categories, product may be deemed adulterated and unfit for consumption (342 (a) (3))

10. FDA Complaints
October 1988-September 1989: 10,923 complaints registered with FDA
25% involved foreign objects in food or drink
14% resulted in illness or injury from foreign objects
Examples: glass, slime/scum, metal, plastic, stones/rock, crystals/capsules, shells/pits, wood, and paper
Most (82%) were reported by consumers and not health professionals

11. Chocolate and Cocoa Products
Eight Most Common Food Categories Implicated In Reported Foreign Object Complaintsa
Food Category
Number of Complaints
Percentb
Bakery
227
8.3
Soft Drinks
228
8.4
Vegetables
226
Infant Food
187
6.9
Fruits
183
6.7
Cereal
180
6.6
Fishery
145
5.3
Chocolate and Cocoa Products
132
4.8
aAdapted from Hyman et al.(1991). Does not include meat and poultry categories or suspected or confirmed tampering complaints. bPercent of total (2726) reported foreign object complaints received by the FDA Complaint Reporting System from 10/1/88 through 9/30/89.

12. Addition of Foreign Objects
Intentional addition is a criminal act
Can be prosecuted under Federal Anti-Tampering Act (FBI) if intent is fraud or sabotage
Cannot imbed foreign objects in confectionary products (342 (a) (1))

13. Methods to Control Hard or Sharp Foreign Objects
Raw material specification and inspection
Vendor certification and letters of guarantee
Metal detectors
X-ray technology (bone fragments; plastic materials)
Effective pest management programs
Preventive equipment maintenance programs

14. Flow Chart for Evaluating Significance of Hazards in Foods
Is a contaminant found?
No action is indicated
Yes No
Is the contaminant a
hazard or an indication
of a potential hazard? No
Yes
Is there an effective control to eliminate
or neutralize the hazard?
Immediate correction
action is required
Yes No
Is a contaminant an indication of unsanitary
conditions?
The contaminant may
be an aesthetic defect
Yes No
SSOP or other corrective action is required

15. Questions
Physical hazards are regulated under what sections of Food, Drug, and Cosmetic Act?
What length(s) of hard or sharp object is considered hazardous in the US?
Give examples of two physical hazards and explain how a food plant ensures that the product is free of such hazards
Give methods to prevent or reduce hazards from hard or sharp foreign objects
What can a company do if it finds out that a product with a physical hazard may be in the marketplace?